US10123840B2 - System and method for medical device placement in bone - Google Patents

Abstract

Disclosed herein are device and methods for determining an orientation of an instrument for inserting a medical device in a bone. One such method includes simulating an insertion point and an orientation of a simulated surgical hardware installation on a diagnostic representation of the bone, and then using an electronic device to align an instrument for inserting a surgical hardware installation at a desired orientation through an insertion point of the bone by indicating when an orientation of the electronic device is within a threshold of the simulated orientation.

Description

RELATED APPLICATIONS

This application claims the benefit and priority of previously filed provisional patent application U.S. App. No. 62/145,868, filed Apr. 10, 2015 and titled “SYSTEM AND METHOD FOR PEDICLE SCREW PLACEMENT IN VERTEBRA”, and of previously filed provisional patent application U.S. Appl. No. 62/116,345, filed Feb. 13, 2015, titled “SYSTEM AND METHOD FOR PEDICLE SCREW PLACEMENT IN VERTEBRA”, and the contents of both are hereby incorporated by reference in their entirety.

TECHNICAL FIELD

This disclosure generally relates to medical systems. More specifically, this disclosure relates to an electronic device that generates output which facilitates the aligning and orientation of surgical equipment for use in inserting a medical device in a bone. In one implementation, the surgical equipment is used to create a pilot hole in a vertebra for receiving a pedicle screw at a precise orientation, such as a transverse angle, sagittal angle, or any other angle.

BACKGROUND

Patients who undergo certain procedures, such as a spinal fusion, may have pedicle screws placed into their vertebrae. The pedicle screws are typically implanted into the vertebrae through the pedicles of the vertebrae. Once a pilot hole is created through the cortex of the bone, a probe is used to create the path through which the pedicle screw will be placed into the vertebrae. Placing the pedicle screw at the correct angle helps to assure a mechanically sound construct and to avoid injury to surrounding structures such as the spinal cord, nerve roots, and blood vessels. The orientation of the screw can be described in two planes: (1) the transverse plane, which is parallel to the ground if the person is standing upright, and (2) the sagittal plane, which divides a person into left and right halves.

To assist surgeons to properly place and orient a pedicle screw in a vertebra, a variety of machines have been used. However, these machines are typically costly and bulky, thereby reducing the number of available surgical suites that have suitable equipment for use in assisting a surgeon with properly placing and orienting a pedicle screw. Therefore, further developments in medical technology are needed so as to enable physically smaller, cost effective devices that provide the desired level of assistance to surgeons.

SUMMARY

This summary is provided to introduce a selection of concepts that are further described below in the detailed description. This summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to be used as an aid in limiting the scope of the claimed subject matter.

A method disclosed herein includes simulating an insertion point and an orientation of a simulated surgical hardware installation on a diagnostic representation of the bone, and then using an electronic device to align an instrument for inserting a surgical hardware installation at a desired orientation through an insertion point of the bone by indicating when an orientation of the electronic device is within a threshold of the simulated orientation.

An apparatus disclosed herein is for determining orientation of an instrument for inserting a medical device in a bone. The apparatus includes an electronic device having an orientation sensor, and a processor. The processor is configured to simulate insertion of the medical device in an image of the bone to determine a desired insertion angle of the medical device relative to a plane of the bone, determine an orientation of the electronic device relative to the plane using the orientation sensor, and output a notification when the orientation of the electronic device is such that the electronic device is positioned adjacent the desired angle of the medical device relative to the plane.

Another method aspect is directed to a method for verifying an insertion angle of an instrument for determining a correct angle for a pedicle screw in a vertebra. The method includes aligning an axis of an apparatus with at least one of a sagittal plane, transverse plane, and coronal plane of the vertebra in a representation thereof. The method also includes capturing an image of the representation of the vertebra, and generating an angle-indicative line on a display, wherein the angle-indicative line adjusts in response to rotation and orientation of the apparatus and provides a notification when the apparatus is at the correct angle, the correct angle being a desired angle between the axis of the apparatus and at least one of the sagittal plane, transverse plane, and coronal plane.

A further aspect is directed to a system for indicating an insertion sagittal angle of a tract for receiving a pedicle screw in a vertebra. The system includes an image acquisition unit, an orientation sensor, a display, and a processor. The processor is configured to obtain an image of a cross sectional view in a transverse plane of the vertebra, using the image acquisition unit, and measure orientation of the system and calibrate the orientation to align with a sagittal plane, transverse plane, or coronal plane of the vertebra. The processor is further configured to receive definitions of an insertion sagittal angle, transverse angle, or coronal angle of the tract and an initial position thereof relative to the vertebra, and generate an angle-indicative line on the display, wherein the angle-indicative line rotates in response to rotation of the system, and provides a notification when at least a portion of the system approximately forms the insertion sagittal angle, transverse angle, or coronal angle between an axis of the apparatus and the sagittal plane, transverse plane, or coronal plane of the vertebrae.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of various embodiments of the present invention and the advantages thereof, reference is now made to the following brief description, taken in connection with the accompanying drawings, appendices, and detailed description, wherein like reference numerals represent like parts, and in which:

FIG. 1 illustrates definitions of a sagittal plane, a frontal plane, and a transverse plane relative to a patient's body;

FIG. 2A illustrates a cross-sectional view of a vertebra having pedicle screws installed in respective pilot holes;

FIG. 2B illustrates an example lateral view of a vertebra for installing pedicle screws;

FIG. 2C illustrates an example posterior view of a vertebra for installing pedicle screws;

FIG. 3A presents a schematic diagram of an apparatus used in accordance with an embodiment to define and verify a sagittal angle for a pilot hole;

FIG. 3B illustrates a schematic diagram for defining a sagittal angle for a pilot hole in a vertebra;

FIG. 4A illustrates a schematic side view of a medical operation system used in some embodiments for defining the sagittal angle of a vertebra;

FIG. 4B illustrates a schematic front view of a medical operation system used in some embodiments for defining the sagittal angle of a vertebra;

FIG. 5A illustrates an example flow chart for a method of determining an orientation of an instrument for inserting a medical device in a bone, in accordance with one or more embodiments of the present disclosure;

FIGS. 5B, 5C, and 5D illustrate example flow charts for methods for indicating the sagittal angle, transverse angle, and coronal angle, respectively, in accordance with one or more embodiments of the present disclosure;

FIGS. 6A-6D illustrate example user interfaces for a computer-implemented program to perform the methods shown inFIGS. 5A-5D, whereinFIG. 6A illustrates an interface for selecting vertebra of a patient,FIG. 6B illustrates aligning the longitudinal axis of the apparatus with the sagittal plane,FIG. 6C illustrates defining a pedicle screw's position and its sagittal angle, andFIG. 6D illustrates generating an angle-indicative line for showing the angle between the longitudinal axis of the apparatus and the sagittal plane;

FIG. 7 illustrates an example application of the aligning method presented inFIG. 5B or 5C; and

Like elements are indicated with like reference numerals.

DETAILED DESCRIPTION

In the following detailed description and the attached drawings and appendices, numerous specific details are set forth to provide a thorough understanding of the present disclosure. However, those skilled in the art will appreciate that the present disclosure may be practiced, in some instances, without such specific details. In other instances, well-known elements have been illustrated in schematic or block diagram form in order not to obscure the present disclosure in unnecessary detail. Additionally, for the most part, specific details, and the like, have been omitted inasmuch as such details are not considered necessary to obtain a complete understanding of the present disclosure, and are considered to be within the understanding of persons of ordinary skill in the relevant art.

It is further noted that, unless indicated otherwise, all functions described herein may be performed in hardware or as software instructions for enabling a computer, radio or other device to perform predetermined operations, where the software instructions are embodied on a computer readable storage medium, such as RAM, a hard drive, flash memory or other type of computer readable storage medium known to a person of ordinary skill in the art. In certain embodiments, the predetermined operations of the computer, radio or other device are performed by a processor such as a computer or an electronic data processor in accordance with code such as computer program code, software, firmware, and, in some embodiments, integrated circuitry that is coded to perform such functions. Furthermore, it should be understood that various operations described herein as being performed by a user may be operations manually performed by the user, or may be automated processes performed either with or without instruction provided by the user.

This disclosure describes a system and computer-implemented method for indicating an angle formed between a guiding direction for drilling a pilot hole (also referred to herein as a tract) for receiving a pedicle screw and a reference plane such as, for example, the sagittal plane.

The disclosed system and method may be implemented to guide the insertion of pedicle screws at a desired angle. The desired angle may be a transverse angle, sagittal angle, or any other angle. This process may include, in some embodiments, the creation of pilot holes.

FIG. 1 illustrates a sagittal ormedian plane110, a coronal orfrontal plane120, and a transverse orhorizontal plane130 relative to a patient'sbody part100 located at the intersection of thesagittal plane110,coronal plane120, andtransverse plane130. Each plane is orthogonal to each other. When discussing a vertebra (or other body parts) in the following disclosure, reference is made to the sagittal plane, coronal plane, and transverse plane. It should be understood that, when these planes are mentioned, they are not intended as a reference to the specific sagittal, coronal, and transverse planes illustrated inFIG. 1, but rather, are intended as a reference to illustrate an orientation or location relative to the specific vertebra being discussed.

FIG. 2A illustrates a cross sectional view (i.e., superior view)200 of avertebra205 havingpedicle screws210 installed in respective pilot holes220. A driver230 may be used to screw the pedicle screws210 into the pilot holes220.FIG. 2B illustrates a lateral view (i.e., side view)250 of a vertebra, andFIG. 2C illustrates aposterior view270 of a vertebra. The following discussion focuses on properly creating the pilot holes with a tool guided by the method disclosed.

FIG. 3A presents a schematic diagram of anapparatus300 used to define and verify an angle for a pilot hole, or tract, such as thepilot hole220 ofFIG. 2. Theapparatus300 has an axis305 (such as, for example, a longitudinal axis) that is used in some embodiments to align theapparatus300 for image capture. Theapparatus300 includes animage acquisition unit320 for capturing animage310 of the vertebra. In some embodiments, theimage310 may be obtained by positioning theapparatus300 and/orimage acquisition unit320 in parallel with the transverse, sagittal, or coronal plane to obtain an image of the vertebra.

In some embodiments, theimage acquisition unit320 can be a camera having sufficient field ofview360 to properly align theaxis305 of theapparatus300 with the desired plane. In some embodiments, theaxis305 is representative of a vertical line centered laterally with respect to the image being captured. For example, if the desired image is intended to capture the vertebra from a cross sectional, superior view (e.g., seeFIG. 2A), theaxis305 is aligned with the sagittal plane (i.e., the plane that is sagittal to the vertebra) and theimage acquisition unit320 is positioned parallel to the transverse plane to capture the top-down view of the vertebra shown inFIG. 2A. If the desired image is intended to capture the vertebra from a side view (e.g., a lateral image of the vertebra, seeFIG. 2B), theaxis305 is aligned with the transverse plane (i.e., the plane that is transverse to the vertebra) and theimage acquisition unit320 is positioned parallel to the sagittal plane. If the desired image is intended to capture the vertebra from a posterior or anterior view (see, for example,FIG. 2C), theaxis305 is aligned with the sagittal plane and theimage acquisition unit320 is positioned parallel to the coronal plane.

In some embodiments, theimage310 may be a processed image, e.g., an image displayed on a screen, a film, or a printed photograph. In other embodiments, theimage acquisition unit320 can directly use an image taken from an external machine (not illustrated), such as a radiograph, computed tomography (CT) scanner, or a magnetic resonance imaging (MRI) machine.

Theorientation apparatus330 is operable to detect changes in movement, orientation and position. In some embodiments, theorientation apparatus330 includes at least one of agyroscope332, aninertial measurement unit334, and anaccelerometer336. Thegyroscope332 is operable to measure at least one axis of rotation, for example, the axis parallel to the intersection of the sagittal plane and the coronal plane. In other embodiments, thegyroscope332 includes more than one sensing axes of rotation, such as three axes of rotation, for detecting changes in orientation. Theinertial measurement unit334 can detect changes of position in one or more directions in a cardinal coordinate system. Theaccelerometer336 can detect changes of speeds in one or more directions in a cardinal coordinate system. In some embodiments, data from all components of theorientation apparatus330 are used to calculate the continuous, dynamic changes in orientation and position.

Theapparatus300 further includes, in some embodiments, aninput component340 that is operable to receive user input, and insertion location and the desired angle representing an insertion direction of the pedicle screw. An example illustration of theuser input component340 is presented in accordance withFIGS. 6A-6D. In some embodiments, theinput component340 can include a multi-touch screen, a computer mouse, a keyboard, a touch sensitive pad, or any other input device.

In some embodiments, theapparatus300 further includes aprocessor350. Theprocessor350 can be any processing unit capable of basic computation and capable of executing a program, software, firmware, or any application commonly known in the art of computer science. As to be explained, theprocessor350 is operable to output an angle-indicative line representing the apparatus orientation on the display. In some embodiments, the angle-indicative line provides a notation that the orientation of theapparatus300 approximately forms the desired angle. The angle-indicative line is not limited to showing sagittal angles, but also angles in different planes, such as, for example, the coronal plane or the transverse plane.

Theapparatus300 may, in some embodiments, further include amemory storage unit352 andnetwork module354. Thememory storage unit352 can be a hard drive, random access memory, solid-state memory, flash memory, or any other storage device.Memory storage unit352 saves data related to at least an operating system, application, and patient profiles. Thenetwork module354 allows theapparatus300 to communicate with external equipment as well as communication networks.

In some embodiments, theapparatus300 further includes adisplay360. In some embodiments, thedisplay360 is a liquid crystal display for a multi-touch screen. In some embodiments, thedisplay360 shows the angle-indicative line to a user and provides a notification when the apparatus is approximately aligned with the predefined desired angle. For example, the notification can include a highlighted line that notifies the user theaxis305 has reached the desired angle, or is within an acceptable range of the desired angle.

Referring briefly toFIG. 7, in some implementations, theapparatus300 further includes an attachment support or mechanism that allows theapparatus300 to be attached to medical equipment, for example, for creating the pilot holes as shown inFIG. 7. Theattachment mechanism700 may be comprised of plastic, stainless steel, titanium, or any other material. Theattachment mechanism700 couples theapparatus300 to theequipment702 by, for example, providing a casing that is attached to the apparatus701 and is configured to connect to theequipment702. In some embodiments, theattachment mechanism700 may include a magnetic attachment apparatus for coupling theapparatus300 to theequipment702. Theattachment mechanism700 allows theapparatus300 to provide real-time measurement and display of the orientation of the attachedmedical equipment702.

FIG. 3B illustrates a schematic diagram for defining thesagittal angle370 for thepilot hole220 in thevertebra205. The field ofview360 of theimage acquisition unit320 allows a user to align theaxis305 of theapparatus300 with the desired plane (e.g., the sagittal plane). In the embodiment shown inFIG. 3B, thesagittal angle370 is the angle between thecentral axis365 of thepilot hole220 and the sagittal plane.

FIG. 4A illustrates a schematic side view of amedical operation system400, which may be used in some embodiments for defining thesagittal angle370 of the vertebra shown inFIGS. 3A and 3B. Themedical operation system400 includes amachine410 for capturing a cross-sectional view of thevertebra205. Themachine410 may be, for example, a CT scanner or MRI machine. The patient108 exits themachine410 after the image is taken, as shown inFIG. 4B.

FIG. 4B illustrates a schematicfront view450 of themedical operation system400 taken in the transverse plane for defining thesagittal angle370 of thevertebra205. The axis of thepilot hole460 should to be precisely defined for thedrilling guide455. In some embodiments, theapparatus300 may be attached to thedrilling guide450 with theattachment mechanism308. Defining and verifying thesagittal angle370 may be performed at theapparatus300, as explained in connection with the method illustrated inFIG. 5B.

First, however, a method of determining an orientation of an instrument for inserting a medical device in a bone is now described with reference to theflowchart501 ofFIG. 5A.

First an insertion point and an orientation of a simulated surgical hardware installation are simulated on a diagnostic representation of abone502. Then, an electronic device is used to align an instrument for inserting a surgical hardware installation at a desired orientation through an insertion point of the bone by indicating when an orientation of the electronic device is within a threshold of thesimulated orientation503.

Simulating the insertion point and the orientation of the simulated surgical hardware installation on the diagnostic representation of the bone includes acquiring the diagnostic representation of thebone504, aligning the diagnostic representation of the bone with areference point505, designating the insertion point of the simulated surgical hardware installation on the diagnostic representation of thebone506, and designating the orientation of the simulated surgical hardware installation on the diagnostic representation of the bone relative to thereference point507.

Using the electronic device to align the instrument for inserting the surgical hardware installation at the desired orientation through the insertion point includes aligning the electronic device with the instrument at theinsertion point508, tracking movement of the electronic device and the instrument using an orientation sensor of the electronic device until the orientation of the electronic device and the instrument are within the threshold of thesimulated orientation509, and indicating when the electronic device and the instrument are within the threshold of thesimulated orientation511.

FIG. 5B illustrates anexample flow chart500 of a method for indicating thesagittal angle370. The method of theflowchart500 is for verifying anyinsertion angle370 of thepilot hole220 in thesagittal plane110 for receiving apedicle screw210 in thevertebra205. At510, theaxis305 of theapparatus300 is aligned with the sagittal plane. In some embodiments, a user may hold theapparatus300 and rotate theapparatus300 to match a marking indicating theaxis305 with features of thevertebra205 that indicate the sagittal plane. In some embodiments, the marking may be displayed on the screen as the user aligns the device.

At520, the image of the cross-sectional view is captured in the transverse plane. In one embodiment, theapparatus300 includes a smart phone, a tablet computer, a laptop computer, or any portable computational device including those that include a camera for capturing a representation of the cross-sectional view of thevertebra205. In other embodiments, the image of thevertebra205 may be sent to theapparatus300 via a wired or wireless connection to be displayed on theapparatus300 such that no physical representation (e.g., films, photos, monitors) may be needed for this step.

At530, definitions of the insertionsagittal angle370 of thepilot hole220 and theinitial position375 of the pilot hole are provided by a user. This input operation may be performed using various input devices, including a computer mouse, a keyboard, a touchscreen, or the like. In one embodiment, a multi-touch screen (e.g., the display360) is used for both displaying the image and receiving the definition input from a user. Example illustrations of this input are provided inFIGS. 6A-6D.

At540, an angle-indicative line is generated by a processor and displayed on thedisplay360. The angle-indicative line can rotate in response to theapparatus300 rotation and provides a notification when theapparatus300 approximately forms the insertionsagittal angle370 between theapparatus300longitudinal axis305 and the sagittal plane. In some implementations, the angle-indicative line is a rotating line generated in thedisplay360 that allows a user to constantly monitor the change of orientation of theapparatus300. The orientation monitoring is performed with anorientation apparatus330. More specifically, in some embodiments, agyroscope332 that includes at least one axis of rotation may provide the function of monitoring the apparatus's orientation or position.

The indicative line may generate notations in various forms, including a visual alert such as highlighting the angle-indicative line, an audio alert such as providing a continuous sound with variable frequency indicative of the proximity between the current angle and the desired angle, and a small vibration that allows the user to notice the angular change. It should be appreciated that any audio alert may be used, such as a single sound or series of sounds when the desired angle is reached. Likewise, a single vibration or a series of vibrations may be emitted when the desired angle is reached. In some implementations, theflow chart500 illustrated inFIG. 5B may be applicable for generating indication angles in the transverse plane or the coronal plane for indicating a respective transverse angle or a coronal angle.

FIG. 5C illustrates aflow chart550 of an implementation for indicating a transverse angle, which is an angle with respect to the transverse plane of the vertebra. The method of theflowchart550 is for verifying any pedicle screw insertion angle in the transverse plane of thevertebra205. At560, theaxis305 of theapparatus300 is aligned with the transverse plane. In some embodiments, a user may hold theapparatus300 and rotate theapparatus300 to match a marking indicating theaxis305 with features of thevertebra205 that indicate the transverse plane. In some embodiments, the marking may be displayed on the screen as the user aligns the device.

At570, the image of the posterior view is captured in the coronal plane. In one embodiment, theapparatus300 includes a smart phone, a tablet computer, a laptop computer, or any portable computational device including those that include a camera for capturing a representation of the cross-sectional view of thevertebra205. In other embodiments, the image of thevertebra205 may be sent to theapparatus300 via a wired or wireless connection to be displayed on theapparatus300 such that no physical representation (e.g., films, photos, monitors) may be needed for this step.

At580, definitions of the insertion angle in thetransverse plane130, and theinitial position375 of the pilot hole are provided by a user, as similar to the sagittal angle defined at530.

At590, an angle-indicative line for the corresponding transverse angle is generated by a processor and displayed on thedisplay360. The angle-indicative line can rotate in response to theapparatus300 rotation and provides a notification when theapparatus300 approximately forms the insertion transverse angle, as defined instep580, between theapparatus300longitudinal axis305 and the transverse plane. In some implementations, the angle-indicative line is a rotating line generated in thedisplay360 that allows a user to constantly monitor the change of orientation of theapparatus300. The orientation monitoring is performed with anorientation apparatus330. More specifically, in some embodiments, agyroscope332 that includes at least one axis of rotation may provide the function of monitoring the apparatus's orientation or position.

FIG. 5D illustrates aflow chart555 of another implementation for indicating a coronal angle. The method of theflowchart555 is for verifying any insertion angle of apedicle screw210 in thevertebra205 in thecoronal plane120. At565, theaxis305 of theapparatus300 is aligned with the coronal plane. In some embodiments, a user may hold theapparatus300 and rotate theapparatus300 to match a marking indicating theaxis305 with features of thevertebra205 that indicate the coronal plane. In some embodiments, the marking may be displayed on the screen as the user aligns the device.

At575, the image of the lateral view is captured in the sagittal plane. In one embodiment, theapparatus300 includes a smart phone, a tablet computer, a laptop computer, or any portable computational device including those that include a camera for capturing a representation of the posterior view of thevertebra205. In other embodiments, the image of thevertebra205 may be sent to theapparatus300 via a wired or wireless connection to be displayed on theapparatus300 such that no physical representation (e.g., films, photos, monitors) may be needed for this step.

At585, respective definitions of the insertion angle in thecoronal plane120, and theinitial position375 of the pilot hole are provided by a user, as similar to the sagittal angle defined at530.

At595, an angle-indicative line for one of the corresponding coronal angle is generated by a processor and displayed on thedisplay360. The angle-indicative line can rotate in response to theapparatus300 rotation and provides a notification when theapparatus300 approximately forms the insertion coronal angle between theapparatus300longitudinal axis305 and the coronal plane. In some implementations, the angle-indicative line is a rotating line generated in thedisplay360 that allows a user to constantly monitor the change of orientation of theapparatus300. The orientation monitoring is performed with anorientation apparatus330. More specifically, in some embodiments, agyroscope332 that includes at least one axis of rotation may provide the function of monitoring the apparatus's orientation or position.

FIGS. 6A-6D illustrate examples of user interfaces for controlling a computer implemented program to perform the methods shown inFIG. 5A-5D.FIG. 6A illustrates aninterface600 for selecting vertebra of a patient,FIG. 6B illustrates aligning theaxis305 of theapparatus300 with the sagittal plane,FIG. 6C illustrates defining a pedicle screw's position and itssagittal angle370, andFIG. 6D illustrates generating an angle-indicative line652 for showing the angle between the longitudinal axis of the apparatus and the sagittal plane. In some embodiments, the angle-indicative line may represent a virtual gearshift probe, or other instrument for aligning a pedicle screw or pilot hole. Where the virtual gearshift is properly aligned, the virtual gearshift may change colors, or may change length or width. The angle-indicative line can rotate in response to theapparatus300 rotation and provides a notification when theapparatus300 approximately forms the insertion coronal angle between theapparatus300longitudinal axis305 and the coronal plane.

InFIG. 6A, the patient's profile may be selected or added by typing the last name of the patient in thewindow610. The corresponding vertebra for the desired angle is selected in thewindow620. Thecamera button640 allows a user to take a picture of the vertebra. The picture is then shown in thewindow630. Thebutton650 allows the user to move onto the next step. As previously discussed, the picture at the vertebra may be provided without use of the camera orcamera button640.

For example, by using a camera of a mobile device, a user can take a picture of an axial view (either CT or MRI) in thetransverse plane130, of the desiredvertebral body205. Use thered line622 to line up the vertebral body so that it is proximately vertical for aligning with the sagittal plane (or other desired plane), as shown inFIG. 6B. Aretake button624 allows the user to go back to the previous steps to retake the image to ensure the alignment is proper. Thebutton626 allows the user to select the current photo to be used in the following operations.

After selectingbutton626, the user may be returned to the detail view as shown inFIG. 6C. The photo may, in some embodiments, be automatically flipped to approximate its position during surgery.Button642 may be selected to flip the orientation of the photo. For example, theRL button642 can be used to flip the picture (and pedicle screw) depending on whether the surgeon is placing the screw while looking towards the patient's head or towards their feet.

The user next selects the optimal pedicle screw position by selecting thenavigation button644 and by moving thecrosshairs633 to the cortical entry point of the screw, then tapping thetrajectory button634 and rotate the screw to its desiredposition635.

Tap theNav button644 and avirtual gearshift probe652 appears on the screen. The gearshift probe's orientation matches the orientation of theapparatus300. In some embodiments, once the angle of thegearshift probe652 is about 20 degrees within the selected trajectory, thegearshift probe652 will turn yellow, at 5 degrees, it will turn green, and when the alignment is within 1 degree of the target angle, agreen line654 will extend outward and the pedicle screw will disappear.

In some embodiments, the device orapparatus300 can be placed in a sterile bag and then be placed against the gearshift probe as it is being used to create the path for the pedicle screw.

Some gearshift probes may be too short to allow the device (apparatus300) to be placed against them lengthwise. If this is the case, tap the 90degree button656 and the screen will be rotated so the short edge of the device can be placed against the gearshift probe.

Other implementations of the disclosed system and method are possible. For example, theapparatus300 may also use a second or more views to define various angles not limited within the sagittal plane. For example and in accordance with the foregoing disclosure, images may be captured from the superior, lateral, posterior, anterior views, and various combinations thereof, to provide multiple reference points so that three-dimensional representations of the alignment angles can be presented.

In addition, different mobile computer devices may be used or modified into theapparatus300 by equipping corresponding image acquisition units, input terminals, and motion or orientation sensing units. In some embodiments, theapparatus300 includes a smart phone or another electronic device having a gyroscope. In addition, other motion or orientation sensors may be included such as theinertial measurement unit334, and theaccelerometers336. Theapparatus300 may also be attached onto various medical devices or equipment for guiding insertion angles that require high precision and ease of use. The smartphone may be an iPhone for example. Also, in some application, the mobile computer device may be an iPod Touch, iPad, Android phone, Android tablet, Windows Phone, Windows tablet, or Blackberry phone. Also, in some applications, the mobile computer device may be an Apple TV in combination with an Apple TV remote, or a Nintendo Wii in combination with a Nintendo Wii remote. Indeed, the mobile computer device may be any combination of electronic devices where the orientation sensor (such as a gyroscope) is in one electronic device and the processor is in another electronic device.

In some embodiments, axis other than the device's longitudinal axis may be used. Axes can be defined by a portion of the device (e.g., an edge or surface of the device). More than oneorientation apparatus330 may be used at the same time to give a three-dimensional viewing. Surgical apparatus may include pedicle screws, gearshift probes, and other medical devices.

Although the preceding description has been described herein with reference to particular means, materials and embodiments, it is not intended to be limited to the particulars disclosed herein; rather, it extends to all functionally equivalent structures, methods, and uses, such as are within the scope of the appended claims.

Claims (14)

The invention claimed is:

1. An apparatus for determining orientation of an instrument for inserting a medical device in a bone, the apparatus comprising:

an electronic device comprising:

an orientation sensor;

a processor configured to:

simulate insertion of the medical device in an image of the bone to determine a desired insertion angle of the medical device relative to a plane of the bone;

determine an orientation of the electronic device relative to the plane using the orientation sensor, while a diagnostic representation of the bone is displayed by the electronic device;

output a notification when the orientation of the electronic device is such that the electronic device is positioned adjacent the desired insertion angle of the medical device relative to the plane of the bone, wherein the notification includes a first graphical element representing the orientation of the electronic device and a second graphical element representing the desired insertion angle of the medical device.

2. The apparatus ofclaim 1, wherein the processor is further configured to use an additional image of the bone to determine when the electronic device is positioned adjacent an additional desired insertion angle with an additional plane of the bone, and to output an additional notification when the electronic device is positioned adjacent the additional desired insertion angle.

3. The apparatus ofclaim 1, wherein the image of the bone is a superior view of the bone, a lateral view of the bone, or a posterior view of the bone.

4. The apparatus ofclaim 1, wherein the image of the bone is a pictoral view of the bone, an x-ray of the bone, a radiograph of the bone, a computed tomography scan of the bone, or a magnetic resonance image of the bone.

5. The apparatus ofclaim 1, wherein the plane is a transverse plane, coronal plane, or a sagittal plane.

6. The apparatus ofclaim 1, wherein the processor determines the orientation of the electronic device by determining an orientation of a longitudinal axis of the electronic device.

7. The apparatus ofclaim 1, wherein the medical device comprises a screw or a probe.

8. The apparatus ofclaim 1, wherein the bone comprises a vertebrae.

9. The apparatus ofclaim 1, further comprising an attachment mechanism for affixing the electronic device to the instrument for creating a tract in the bone for receiving the medical device.

10. The apparatus ofclaim 1, wherein the orientation sensor comprises at least one of a gyroscope, an accelerometer, and an inertial measurement unit.

11. The apparatus ofclaim 1, wherein the first graphical element is a first angle-indicative line and the second graphical element is a second angle indicative line.

12. A system for indicating an insertion sagittal angle of a tract for receiving a pedicle screw in a vertebra, the system comprising:

an image acquisition unit;

an orientation sensor;

a display;

a processor configured to:

obtain an image of a cross sectional view in a transverse plane of the vertebra, using the image acquisition unit;

measure orientation of the system and calibrate the orientation to align with a sagittal plane, transverse plane, or coronal plane of the vertebra, while a diagnostic representation of the bone is displayed in the display;

receive definitions of an insertion sagittal angle, transverse angle, or coronal angle of the tract and an initial position thereof relative to the vertebra; and

generate an angle-indicative line on the display, wherein the angle-indicative line rotates in response to rotation of the system, and provides a notification when at least a portion of the system approximately forms the insertion sagittal angle, transverse angle, or coronal angle between an axis of the apparatus and the sagittal plane, transverse plane, or coronal plane of the vertebrae, wherein the image acquisition unit, the orientation sensor, the display, and the processor are integrated into a single handheld electronic device.

13. The system ofclaim 12, wherein the orientation sensor comprises at least one of a gyroscope, an accelerometer, and an inertial measurement unit.

14. The system ofclaim 13, wherein the gyroscope is operable to measure at least one axis of rotation.

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